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Assessment of the nasal residence time of AM-301 nasal spray

Organizational Data

DRKS-ID:
DRKS00025692
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2021-07-05
Last update in DRKS:
2023-03-13
Registration type:
Prospective

Acronym/abbreviation of the study

AM-301-CL-20-03

URL of the study

http://nicht vorhanden

Brief summary in lay language

The present study is being conducted to determine the nasal residence time for AM-301 and thereby estimate the duration of protection. AM-301 is applied as a nasal spray. AM-301 forms a protective layer on the nasal mucosa. This protective layer acts, among other things, as a mechanical barrier against allergens. Healthy male study participants will receive either 1 spray of AM-301 per nostril (Group A) or 2 sprays of AM-301 per nostril (Group B). To conduct this study, the formulation will be stained with a fluorescent dye prior to administration. In a control group (Group C), fluorescein (0.1%) is administered in a commercially available isotonic saline nasal spray. The residence time of the gel/protective layer in the nose will be assessed using an endoscope at specified intervals. In addition, the safety and tolerability of AM-301 will be evaluated.

Brief summary in scientific language

This is a monocentric study to determine the nasal residence time of AM-301 Nasal Spray. The test product to be administered is AM-301 Nasal Spray stained with fluorescein sodium to allow visualization in the nasal cavity and pharynx. Four subjects each will be included in group A and group B. Subjects will be administered either one spray of AM-301 (0.14 mL - Group A) or two sprays of AM-301 (2x 0.14 mL - Group B) into each nostril. In control group C, either 1 spray or 2 sprays of the isotonic saline nasal spray are administered into each nostril. The investigator will then assess the presence and intensity of the stained test product by rhinoscopy at specified time points. In addition, the leakage of stained test product in the posterior oropharynx will be checked at 5-minute intervals. Nasal residence time is defined as the time from application to disappearance of the test substance from the middle and inferior turbinates. The maximum observation time is four hours (240 min).

Health condition or problem studied

Free text:
Study on healthy male subjects
Healthy volunteers:
Yes

Interventions, Observational Groups

Arm 1:
Administration of one spray of AM-301 into each nostril (0.14 mL - Group A).
Arm 2:
Administration of two sprays of AM-301 into each nostril (2x 0.14 mL - group B).
Arm 3:
Administration of one or two sprays of saline nasal spray into each nostril (0.14 mL per spray, Group C).

Endpoints

Primary outcome:
Nasal residence time defined as time from application to the disappearance of test product from the middle and inferior turbinates. Distribution of stained test product within nasal cavity will be evaluated (presence “intense”, “moderate”, “minimal” or “absent” at anterior end of middle and inferior turbinate) at 1, 5, 10, 20, 30, 45, 60 minutes, then every 30 minutes until up to 240 minutes, or until no more stained test product visible following application.
Secondary outcome:
Time from application to the observed appearance of a broad stained front in the oropharynx for 10 minutes.

Study Design

Purpose:
Prevention
Allocation:
Non-randomized controlled study
Control:
  • Other
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Medical center Tübingen Universitätsklinikum Tübingen

Recruitment period and number of participants

Planned study start date:
2021-07-06
Actual study start date:
2021-08-04
Planned study completion date:
No Entry
Actual Study Completion Date:
2021-12-08
Target Sample Size:
12
Final Sample Size:
12

Inclusion Criteria

Sex:
Male
Minimum Age:
18 Years
Maximum Age:
50 Years
Additional Inclusion Criteria:
• Healthy, non-smoking male, with age from 18-50 years. • Body Mass Index (BMI) of 18.0-25.0 kg/m2;

Exclusion Criteria

Main exclusion criteria: • Any clinically relevant nasal obstruction or pathology precluding effective and/or efficient intranasal delivery (controlled by endoscopy of the nasal cavity). • Any treatment with nasal treatments within 30 days prior to the assessment visit (including nasal spays, nasal drops and saline washes). • Any clinically relevant medical history or concomitant medication, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject’s ability to participate in the study.

Addresses

Primary Sponsor

Altamira Medica AG
Thomas Meyer
Bahnhofstrasse 21
6300 Zug
Switzerland
Telephone:
+41612011350
Fax:
+41612011351
Contact per E-Mail
URL:
https://www.altamiramedica.com/
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Altamira Medica AG
Dr. Nicole Grosse
Bahnhofstrasse 21
6300 Zug
Switzerland
Telephone:
+41612011350
Fax:
+41612011351
Contact per E-Mail
URL:
https://www.altamiramedica.com/

Contact for Public Queries

Universitätsklinikum Tübingen Klinik für Hals-, Nasen- u. Ohrenheilkunde
Viola Wierschin
Elfriede-Aulhorn-Str. 5
72076 Tübingen
Germany
Telephone:
0049 7071 29-88155
Fax:
0049 7071 29-25324
Contact per E-Mail
URL:
No Entry

Principal Investigator

Altamira Medica AG
Dr. Nicole Grosse
Bahnhofstrasse 21
6300 Zug
Switzerland
Telephone:
+41612011350
Fax:
+41612011351
Contact per E-Mail
URL:
https://www.altamiramedica.com/

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Altamira Medica AG
Bahnhofstrasse 21
6300 Zug
Switzerland
Telephone:
+41612011350
Fax:
+41612011351
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
Gartenstr. 47
72074 Tübingen
Germany
Telephone:
+49-7071-2977661
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-03-26
Ethics committee number:
258/2021MPG1
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-05-05

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
CIV-21-03-036105

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Sailer MM, Köllmer M, Masson B, Fais F, Hohenfeld IP, Herbig ME, Koitschev AK, Becker S. Nasal residence time and rheological properties of a new bentonite-based thixotropic gel emulsion nasal spray - AM-301. Drug Dev Ind Pharm. 2023 Feb 28:1-12. doi: 10.1080/03639045.2023.2183724. Epub ahead of print. PMID: 36852769.
Date of first publication of study results:
2023-02-28
DRKS entry published for the first time with results:
2023-03-13

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry